510(k) K102543 ยท FFT Electrode, Ph, Stomach
BRAVO PH MONITORING SYSTEM AND ACCESSORIES
| Applicant | Given Imaging , Ltd., Yoqneam, IL |
| Decision | Substantially Equivalent, Dec 1, 2010 |
| Received | Sep 3, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102543
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2025 | Given Imaging Ltd. Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack) Open, Classified |
FFT | None listed |
| Feb 26, 2021 | Covidien Llc CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. Open, Classified |
FFT | None listed |
| Feb 26, 2021 | Covidien Llc BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. Open, Classified |
FFT | None listed |
| Feb 6, 2012 | Given Imaging Ltd. Bravo pH Monitoring capsule, UPC 7290101361695 (FGS# 0312) and UPC 7290101361688 (FGS# 0313).
Product Usage:
The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement Terminated |
LLT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.